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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000023490 |
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Date of registration:
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05/08/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The Safety and Efficacy of 5-Aminolevulinic Acid (ALA) Therapy for Sideroblastic Anemia
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Scientific title:
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The Safety and Efficacy of 5-Aminolevulinic Acid (ALA) Therapy for Sideroblastic Anemia - The Safety and Efficacy of 5-Aminolevulinic Acid (ALA) Therapy for Sideroblastic Anemia |
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Date of first enrolment:
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2016/08/20 |
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Target sample size:
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5 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027057 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not applicable
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Countries of recruitment
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Japan
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Contacts
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Name:
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Fujiwara Tohru |
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Address:
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2-1 Seiryo-cho, Aoba-ku, Sendai
Japan |
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Telephone:
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022-717-7165 |
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Email:
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fujiwara-to@apple.email.ne.jp |
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Affiliation:
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Tohoku University Graduate School of Medicine Department of Hematolgy and Rheumatology |
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Name:
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Harigae Hideo |
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Address:
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2-1 Seiryo-cho, Aoba-ku, Sendai
Japan |
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Telephone:
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022-717-7165 |
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Email:
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harigae@med.tohoku.ac.jp |
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Affiliation:
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Tohoku University Graduate School of Medicine Department of Hematolgy and Rheumatology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) Thrombocytopenia (less than 100,000), neutropenia (less than 1,500) 2)Patients who do not understand the study. 3) Serious complication (renal insufficiency with Ccr < 30 ml/min, liver insufficiency with total bilirubin >2 mg/dL, hypoxia requiring home oxygen therapy)
Age minimum:
20years-old
Age maximum:
80years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Sideroblastic anemia (congenital and acquired)
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Intervention(s)
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Food supplement containing 150 mg of ALA phosphate was given per day for 24 weeks. For the evaluation of efficacy and safety, medical examinations as well as urine and blood tests will be performed prior to administration of ALA, then at 2 and 4 weeks, and thereafter every month (up to 12 months).
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Primary Outcome(s)
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To evaluate if ALA responds to the therapy, hemoglobin levels at 12 and 24 weeks will be compared with the data at pre-treatment. Effectiveness is defined as more than 1g/dL increase in hemoglobin level (if the case undergoes regular red blood cell transfusion, the effectiveness is defined as achieving transfusion withdrawal.).
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Secondary Outcome(s)
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Onset of adverse event is evaluated at 2 weeks, 4 weeks, and thereafter every 4 weeks up to 12 months. The grade is defined according o the Common Terminology Criteria for Adverse Events (CTCAE) v4 guideline.
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Source(s) of Monetary Support
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Other
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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